Description
Qualified Person - Bio-pharmaceuticalsType - initially 7-8 months
Location - Ireland, South West
One of our global Pharmaceutical leaders are looking for a Qualified Person to join their team to work in the Bio-pharmaceutical sterile manufacturing facility.
The above position will be working with the Quality Department within the Sterile team and have the following responsibilities:
• Execute the responsibilities of a Qualified Person as per Annex 16
• Perform the QP Release of both commercial and clinical Finished Products manufactured on site,
• Lead and participate as a team member in Quality Continuous Improvement projects
• Provide QP Guidance to the site
• Participate in Investigations / Fact Finding Meetings as required and drive CAPA effectiveness.
• Ensure compliance with cGMP and other business compliance regulations and Procedures.
• Participation in Corporate/Regulatory Inspections on site when required.
• Training and development of area personnel
• Delivery of area performance to meet or exceed performance or quality goals.
• Active participation at the Deviation Review Board, Stability Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
• Lead, promote and participate in the implementation and maintenance of the SHE programmes, where relevant.
The successful candidate should possess:
• A relevant Third Level science qualification, a QP Qualification and will have relevant experience in a Pharmaceutical Environment, preferably in a Sterile Manufacturing Facility. Leadership skills
• Technical knowledge
• Ability to respond to changing priorities
• Problem solving skills
• Communication skills